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PR News Wire (Free subscription) | 11/19/2009
MUNSTER, Germany, November 19 /PRNewswire/ -- MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA). Levodopa-induced dyskinesia is a complication of the mainstay treatment in advanced Parkinson's and a...
5Vote!
Red Orbit (Free subscription) | 11/19/2009
MUNSTER, Germany, November 19 /PRNewswire/ -- MONITORING FORCE GmbH announced that they have filed on November 16th, 2009 Flibanserin in the indication treatment-relevant levodopa-induced dyskinesia in Parkinson's disease for orphan drug status designation with the European Medicines Agency (EMEA).
5Vote!
Startup Professionals Musings (Free subscription) | 11/18/2009
In addition to the “green” sector, which I outlined a few weeks ago , I see biotech as one of the places where startups can always go for real opportunities. Recession-proof products with innovation continue to come from the biotechnology industry. Plus, it was one of the top three categories attracting VC money in the most recent quarter of 2009 . In its most general sense, biotech is...
3Vote!
Medical News Today (Free subscription) | 11/16/2009
Apogenix GmbH, a biopharmaceutical company developing novel drugs for malignant and inflammatory diseases, announced that the European Medicines Agency adopted a positive opinion on orphan medicinal product designation for the company's lead candidate APG101 for the treatment of Glioblastoma multifome (GBM), and that it has already been granted orphan drug status in the US by the US Food and Drug Administration...
5Vote!
Business Wire (Free subscription) | 11/16/2009
IRVINE, Calif. & KIEL, Germany--(BUSINESS WIRE)--Proteo, Inc. (OTCBB: PTEO; Frankfurter Freiverkehr: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma....
3Vote!
Medical News Today (Free subscription) | 11/11/2009
Ikano Therapeutics, Inc. (ITI) announced that it has received Orphan Drug designation for midazolam in the acute treatment of certain forms of epileptic seizure known as cluster seizures or alternatively, as acute repetitive seizures. ITI has a nasally administered form of midazolam called ITI-111 in late stage clinical development that is aimed at the treatment of these specific seizure types in an...
5Vote!
ABC News (Free subscription) | 11/09/2009
Orphan drug treatment used only on mice to get hearing before FDA.
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Business Wire (Free subscription) | 11/09/2009
SADDLE BROOK, N.J.--(BUSINESS WIRE)--Ikano Therapeutics, Inc. (ITI) announced today that it has received Orphan Drug designation for midazolam in the acute treatment of certain forms of epileptic seizure known as cluster seizures or alternatively, as acute repetitive seizures. ITI has a nasally administered form of midazolam called ITI-111 in late stage clinical development that is aimed at the treatment...
5Vote!
Red Orbit (Free subscription) | 11/09/2009
LONDON, November 9 /PRNewswire/ -- Following the provision of clinical and scientific data to the US Food and Drug Administration (FDA), privately owned UK company Daval International Limited (http://www.davalinternational.com) has been informed that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded an Orphan-Drug designation for the treatment of Amyotrophic Lateral Sclerosis (ALS)....
3Vote!
Medical News Today (Free subscription) | 11/06/2009
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML).
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Living on the frontlines (Free subscription) | 11/05/2009
Below is a press release from Intermune, the company that produces Pirfenidone, the drug the NIH was studying to treat the pulmonary fibrosis of HPS. I thought HPS'ers might like to know that even though our study didn't reach a conclusion, Intermune is going ahead with the results from the IPF trial and seeking FDA approval. That means that if the FDA finds the drug is safe, and if they are convinced...
5Vote!
The East Bay Business Times (Free subscription) | 11/05/2009
Sunesis Pharmaceuticals Inc. said Thursday the U.S. Food and Drug Administration granted orphan drug designation for voreloxin, its treatment of acute myeloid leukemia. (SNSS)
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Fiercebiotech (Free subscription) | 11/05/2009
GenVec is on a roll. A day after winning an orphan drug designation for its pancreatic cancer therapy TNFerade, the developer inked a $22 million development deal with Science Applications International to develop new HIV and flu vaccines. The contract is worth $22 million if all options are exercised and GenVec gets about $2.6 million over the next year. "Given the heightened concerns about...
4Vote!
Stock Market Analysis (Free subscription) | 11/05/2009
Below is a list of some of the largest stock gainers and losers so far in pre market for November 5, 2009. Check out my Hot Stocks to Watch page for the latest updates. Pre Market Stock Gainers - 11/5/09 Sunesis Pharmaceuticals Inc. (SNSS) - Sunesis' Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia Parlux Fragrances Inc. (PARL) - Parlux Q2 profit falls ; sees closing new financing...
3Vote!
aarkstore | 10/21/2009
In order to raise public awareness, 29 February 2008 was dedicated the first European rare disease day (‘a rare day for very special people’), but European payers need no reminding of the significance of rare disease treatments, generally known as orphan drugs. Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard...
4Vote!
aarkstore | 09/17/2009
In order to raise public awareness, 29 February 2008 was dedicated the first European rare disease day (‘a rare day for very special people’), but European payers need no reminding of the significance of rare disease treatments, generally known as orphan drugs. Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard...
1Vote!
aarkstore | 07/25/2009
In order to raise public awareness, 29 February 2008 was dedicated the first European rare disease day (‘a rare day for very special people’), but European payers need no reminding of the significance of rare disease treatments, generally known as orphan drugs. Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard...